Influence of Artificial Tears on Keratometry and Biometry Measurements With Different Devices

Healthy Clinical Trial

Official title:

Influence of Artificial Tears on Corneal Parameter Measurement Using Three Different Devices: Scheimpflug-, Keratometry - and Placido-technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06358456
• Other study ID #: 20-928
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: April 22, 2022

Study information

• Verified date: April 2024
• Source: University Clinic Frankfurt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn about the influence of artificial tears on measurements of healthy eyes with three different devices. The main questions it aims to answer are:

• Do artificial tears alter the measurements of the corneal surface

• Is there a difference between the devices used in this study

This is relevant because high quality measurements improve the postoperative outcome after cataract surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: April 22, 2022
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Healthy eyes

Exclusion Criteria:

• Any prior intraocular surgery or trauma

• Any corneal pathology (ABMD, Fuch's, etc.)

• Active ocular pathology (e.g., amblyopia, ARMD)

• Contact lens wear within 2 weeks of study

• Any corneal relaxing incisions or astigmatic keratotomy

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Artificial tear
Application of low viscosity artificial tears (Artelac EDO). The active ingredient is hypromellose (1.92 mg per 0.6 ml container).

Other:
• No artificial tears
Before artificial tear application, 2 baseline measurements were taken of the cornea without any intervention

Locations

Country	Name	City	State
Germany	Goethe University Hospital	Frankfurt	Hesse

Sponsors (1)

Lead Sponsor	Collaborator
University Clinic Frankfurt

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Roggla V, Leydolt C, Schartmuller D, Schwarzenbacher L, Meyer E, Abela-Formanek C, Menapace R. Influence of Artificial Tears on Keratometric Measurements in Cataract Patients. Am J Ophthalmol. 2021 Jan;221:1-8. doi: 10.1016/j.ajo.2020.08.024. Epub 2020 Aug 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does the application of artificial tears (Artelac EDO) alter the measurement of the anterior surface of the cornea (K mean in Diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6)	Difference of measurement of the mean corneal refractive power in diopters before artificial tear application and after artificial tear application using one of three devices (IOL Master 700, Pentacam AXL or Galilei G6)	Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application
Secondary	Is there any difference in anterior corneal refractive power measurements (K mean in Diopters) between the three different devices (IOL Master 700, Pentacam AXL, Galilei G6) after artificial tear (Artelac EDO) application?	Difference of measurement of the mean corneal refractive power in diopters before artificial tear (Artelac EDO) application and after artificial tear application between the three devices (IOL Master 700 using Keratometry, Pentacam AXL and Galilei G6 using Schmeipflug technology)	Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application
Secondary	Does the application of artificial tears (Artelac EDO) alter the anterior astigmatism measurements (in diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6)	Difference of measurement of the mean corneal astigmatism in diopters before artificial tear (Artelac EDO) application and after artificial tear application using three different devices (IOL Master 700, Pentacam AXL and Galilei G6)	Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application
Secondary	If there is an influence of artificial tears (Artelac EDO) on the measurement of the anterior surface of the cornea (K mean in Diopters) using the devices (IOL Master 700, Pentacam AXL or Galilei G6), how long does it last (in minutes)?	How long does the difference of mean corneal refractive power in diopters before artificial tear (artelac ego) application and after artificial tear application last	Comparison between the baseline measurements and the measurements up to 10 minutes after artificial tear applications